Abdominal Wall Function and Quality of Life and Before and After Incisional Hernia Repair

• Conditions: Hernia, Ventral
• Interventions: Other: Examination of abdominal wall strength changes over time

• Registration Number: NCT02320071
• Lead Sponsor: Bispebjerg Hospital

Brief Summary

The primary objective of the present study is to investigate a possible correlation between abdominal wall function and subjective measures of QoL before and after laparoscopic repair of small- to medium sized incisional hernia.

This prospective study includes 25 patients undergoing laparoscopic incisional hernia repair. Abdominal wall function is examined by determination of maximal truncal flexion and extension with a fixated pelvis using a Goodstrength dynamometer (Metitur Ltd., Jyväskylä, Finland). Subjective scores of QoL (HerQLes), pain (visual analogue scale) and physical activity (International Physical Activity Questionnaire) are assessed. Patients are examined before, one month after and three months after the operation. Furthermore, pulmonary function is examined preoperative and three months postoperative by standard spirometry (forved vital capacity, peak expiratory flow, forced expiratory volume in 1 second) as well as maximum in- and expiratory pressure is measured.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-12-16
• Study First Submitted QC: 2014-12-16
• Study First Posted: 2014-12-19
• Study Start: 2015-01
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-02
• Last Update Posted: 2015-09-03
• Primary Completion: 2016-01
• Study Completion: 2016-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Elective laparoscopic repair for one or more incisional hernias in the midline (at least 5 cm caudal to the xiphoid process and at least 5 cm cranial to the pubic bone), using a synthetic mesh
• Horizontal fascial defect between 3 and 8 cm
• Age between 25 and 75 years
• American Association of Anesthesiologist score between I and III
• Body mass index < 33 kg/m^2

Exclusion Criteria

• Severe musculoskeletal, neurologic or cardiopulmonary disease preventing the patient from climbing stairs or shopping for groceries
• Existing stoma
• Postoperative complications requiring intervention

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with incisional hernia	Examination of abdominal wall strength changes over time	Patients with one or more incisional hernias, combined horizontal fascial defect 3-8 cm, planned for laparoscopic mesh repair. Patients are examined before and one and three months postoperative in regard to abdominal wall function, pain, discomfort, hernia-related quality of life and physical activity level.

Primary Outcome Measures

Name	Time	Method
Abdominal wall strength	Change at three months from baseline examination	Abdominal wall strength measured by Goodstrength Dynamometer before, one and three months after laparoscopic incisional hernia repair.
Hernia-related quality of life	Change at three months from baseline examination	Hernia-related quality of life (HerQLes) before, one and three months after laparoscopic incisional hernia repair.

Secondary Outcome Measures

Name	Time	Method
Forced vital capacity	Change at three months from baseline examination	Forced vital capacity measured by spirometry
Forced expiratorry volume for one second (FEV1)	Change at three months from baseline examination	Forced expiratorry volume for one second measured by spirometry
Maximal inspiratory pressure	Change at three months from baseline examination	Maximal inspiratory pressure measured by pressure monitor
Maximal expiratory pressure	Change at three months from baseline examination	Maximal inspiratory pressure measured by pressure monitor
Physical activity level	Change at three months from baseline examination	International Physical Activity Questionnaire (IPAQ) score before and three months after laparoscopic incisional hernia repair.
Pain	Change at three months from baseline examination	Pain on visual analogue scale (VAS) before and three months after laparoscopic incisional hernia repair.
Discomfort	Change at three months from baseline examination	Discomfort on visual analogue scale (VAS) before and three months after laparoscopic incisional hernia repair.

Trial Locations

Locations (1)

Bispebjerg Hospital; 🇩🇰 Copenhagen NW, Copenhagen, Denmark